HomeMy WebLinkAboutAmerican Kratom Association 10_30_2025
TESTIMONY BEFORE THE COMMITTEE ON REGULATORY REFORM ON HB 4969
MAC HADDOW, SENIOR FELLOW ON PUBLIC POLICY, THE AMERICAN KRATOM ASSOCIATION
October 30, 2025
Mr. Chairman, members of the Committee, thank you for this opportunity to provide testimony
today on HB 4969. I do so on behalf of the more than 24 million kratom consumers in the
United States, and the hundreds of thousands of kratom consumers in the state of Michigan.
The American Kratom Association (AKA) supports HB 4969 because we strongly believe kratom
products should be regulated to:
1. Ensure that kratom products marketed to Michigan consumers are safely formulated
and free from microbial contamination and adulterants;
2. No kratom product should contain a level of the naturally occurring trace amounts of
the metabolite – 7-hydroxymitragynine (7-OH) – that is greater than 2% of the overall
fraction of the compounds in the kratom products, and no greater than 1 mg in a
serving.
3. Every kratom product should be properly labeled, with a recommended serving size to
inform consumers about the proper use of the products;
4. Kratom products should be age-restricted.
Eighteen states have adopted this regulatory framework to protect consumers, and we hope
Michigan will be the next state to do so.
The lack of regulations on kratom over the past two decades has created confusion, and up
until last year it was the FDA that was the primary catalyst for a substantial amount of
disinformation about kratom.
That anti-kratom position at the FDA as changed dramatically as the science on the safety of
natural kratom leaf products has been conducted, and the identification of the chemically
manipulated 7-OH products that pose a significant threat to the safety of consumers has helped
to put the focus on the where the real danger lies.
On July 29, 2025, FDA Commissioner Makary stated clearly the FDA is not focused on natural
kratom leaf products but recommended the classification of chemically manipulated 7-OH
products as Schedule I under the federal Controlled Substances Act.
2
The predatory actions of 7-OH manufacturers to falsely market their products as kratom is
analogous to what happened in the delta-8 debacle where predatory entrepreneurs chemically
manipulated and concentrated amounts of delta-8 THC into dangerous products.
THE SCIENCE ON THE SAFETY OF KRATOM AND THE FDA’S CURRENT POSITION
Prior to 2024, FDA maintained the position that all kratom poses a danger to the public. But the
agency refused to participate in a Hearing ordered by a Federal Judge scheduled on February 8,
2024, in the Southern District of California to provide witnesses and documents to prove the
validity of the FDA’s claims that kratom is a dangerous substance. This case was initiated by the
FDA against an importer who had falsely identified kratom raw materials on the shipping
manifest documents which resulted in a guilty plea. In the sentencing phase of the case, the
Judge wanted more information from the FDA on their claims on the danger of kratom. In an
email from the Assistant U.S. Attorney1 the following explanation was provided to the Court on
why the FDA refused to participate in the Hearing:
“They [FDA] have refused to provide us with witnesses or documents to support
our position . . . The reason they gave was that they have not yet made a
determination regarding whether kratom is dangerous.” (emphasis added)
The reason for that change in FDA’s position reportedly is because FDA has completed a Single
Ascending Dose (“SAD”) study on whether kratom can be safely consumed by humans, and an
abstract of the results of that study were reported at the 3rd International Kratom Symposium
in Orlando, Florida on February 16, 2024. This study concluded that “kratom appears to be well
tolerated in humans at all dose levels.” (emphasis added)
This key finding cleared the solicitation by the FDA for proposals to conduct a Human Abuse
Potential (“HAP”) study to determine whether kratom use results in dependency or addiction,
and the severity if indicated.2 This study is expected to be completed in 3-4 years.
In the SAD study, the FDA found that only two human subjects of the 40 participants
experienced nausea only after the consumption of 12 grams of kratom, 24 capsules, within 5-
minutes. The response was the same for both the kratom cohort and the placebo cohort
demonstrating the nausea was related to consuming a high volume of plant material in a 5-
minute period. None of the subjects reached the study’s “stopping criteria” that would have
resulted in termination of the study, but the FDA stopped the study because it concluded that
kratom is well tolerated even at extremely high levels.
FDA has the legal authority to take regulatory action against a manufacturer, distributor, or
vendor of a food product that is adulterated under the standards set forth in the Food, Drug
1 Case 3:23-cr-00179-TWR Filed 12/06/23 Page ID.1032 Exhibit 6; United States of America, Plaintiff, v. Nine2Five,
LLC (1) Sebastian Guthery (2), Defendants
2 https://grants.gov/search-results-detail/351644
3
and Cosmetic Act. It may do so if a food product “bears or contains any poisonous or
deleterious substance which may render it injurious to health, or the food is a dietary
supplement or contains a dietary ingredient that presents a significant or unreasonable risk of
illness or injury under the conditions of use recommended or suggested in labeling.”3 If FDA
finds a food product adulterated, the Agency may take enforcement action against a kratom
company through issuing Warning Letters, Untitled Letters, 483 Inspection Observations, and
Recalls.4
FDA regulates a product based on its intended use as evidenced by the product’s labeling and
claims.5 Kratom, like other products intended to be a food, dietary supplement, or cosmetic, do
not require FDA approval.6 FDA has acknowledged it “does not have premarket approval of
food products.”7 Instead, FDA can approve certain ingredients before they are used in foods
such as food or color additives.8 As such, kratom that is intended to be a food, and not a food or
color additive, is not a product that FDA approves.9 Therefore, it can be legally marketed as
such. In addition, when intended for use as a food, it is immaterial that kratom does not have
any “approved uses,” since food products are not “approved.”10
Kratom can be lawfully marketed and sold as a food. FDA does not preapprove food products.
Although FDA has taken enforcement action against kratom manufacturers and vendors whose
products are intended to be used for other purposes such as an unapproved new drug, the
Agency has never adequately established all kratom is adulterated under required rulemaking
subject to public comment. To the contrary, kratom has been lawfully and safely consumed as a
food by American consumers for decades. Millions of Americans eat or drink kratom every day
to improve their well-being. Kratom can be legally sold under FDA’s laws, rules, and guidance.
Much of the discussion on kratom among policy makers focuses on the webpage FDA has
published, “FDA and Kratom” on its Internet site without notice to the public where the FDA
determined in the webpage that all kratom—in raw leaf and processed, extract forms—is
3 This list is not an exhaustive list. 21 U.S.C. § 342; Questions and Answers Regarding Mandatory Food Recalls, FDA
Guidance, November 2018, available at https://www.fda.gov/media/117429/download.
4 See generally Compliance & Enforcement (Food), FDA.gov, available at https://www.fda.gov/food/compliance-
enforcement-food.
5 See Small Entity Compliance Guide on Structure/Function Claims, 67 Fed. Reg. 1225, Jan. 9, 2002, available at
https://www.federalregister.gov/documents/2002/01/09/02-451/small-entity-compliance-guide-
structurefunction-claims-availability.
6 Unlike those products, FDA requires premarket approval of drugs and many medical devices.
7 Is it really “FDA Approved?”, FDA.gov, January 2017, available at https://www.fda.gov/consumers/consumer-
updates/it-really-fda
approved#:~:text=FDA%20approves%20food%20additives%20in,to%20food%2C%20and%20color%20additives.
8 Id.
9 A food additive includes “any substance the intended use of which results or may reasonably be expected to
result, directly or indirectly … in its becoming a component or otherwise affecting the characteristics of any food.”
21 C.F.R. § 570.3. Food means “articles used for food or drink for man.” 21 U.S.C. § 321. Kratom does not meet an
additive definition, because kratom is itself the food, not the additive.
10 Although premarket approval is not required, food products are regulated by FDA. For example, manufacturers
at a minimum must meet Good Manufacturing Practices, have proper labeling, and register as a food facility.
4
categorically adulterated under the FDCA and therefore not marketable anywhere in the United
States.
The FDA made a significant update on February 22, 2024, to its FDA and Kratom webpage
where they now acknowledge previous characterizations and reports on kratom deaths needed
to be corrected:
“In rare cases, deaths have been associated with kratom use, as confirmed by a
medical examiner or toxicology reports. However, in these cases, kratom was
usually used in combination with other drugs, and the contribution of kratom in
the deaths is unclear.”11
Additionally, the FDA now acknowledges the potential for science to help understand both the
safety and addiction liability where they now correctly viewed through the lens of product
forms and intended use in the consumption of kratom products. This is a dramatic shift from
the FDA’s initial 2016 position where they were calling for a total ban. Here is the excerpt from
the FDA and Kratom webpage on this issue:
“If a new drug application (NDA) is submitted for kratom (or one of its
components) to treat a specific medical condition, FDA will review the scientific
data to determine if a drug product containing kratom (or its components) is safe
and effective to treat that specific medical condition. Consistent with FDA’s
practice with unapproved substances, until the agency scientists can evaluate
the safety and effectiveness of kratom (or its components) in the treatment of
any medical conditions, FDA will continue to warn the public against the use of
kratom for medical treatment. The agency will also continue to monitor
emerging data trends to better understand the substance and its components.”12
THE NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) POSITION ON KRATOM
National Institute on Drug Abuse (NIDA) Director Nora Volkow has testified before Congress
that kratom should not be banned but rather regulated appropriately and new research should
be undertaken. NIDA currently has funded more than $100 million in grants for kratom
research. NIDA researched the FDA claims that kratom caused deaths, and concluded those
deaths were largely from polydrug use or adulterated kratom products.
NIDA Director Nora Volkow has offered two public statements on kratom’s potential value in
the battle against drug overdose deaths. The first was published in NIDA Director Dr. Nora
Volkow’ blog and offered the following assessment of kratom on January 24, 2020:13
11 https://www.fda.gov/news-events/public-health-focus/fda-and-kratom
12 Ibid.
13 https://www.drugabuse.gov/about-nida/noras-blog/2020/01/reviewing-nidas-2019-achievements-looking-to-
future
5
“Research published in June in ACS Central Science provided new insights while
raising new questions about the drug kratom. Its active ingredient mitragynine
acts as a weak partial agonist at the mu-opioid receptor (MOR), but new findings
by a team that included researchers at Columbia and Memorial Sloan-Kettering
found that the drug’s analgesic properties are significantly mediated by a
metabolite produced when mitragynine is consumed orally, called 7-
hydroxymitragynine. In mice, at least, this compound seems to provide analgesia
but with fewer respiratory-depressing and reward-associated side effects than
other opioids such as morphine. These findings point toward the potential of this
drug in pain research as well as the need for further research on the
pharmacology of kratom’s constituents, their toxicity and potential value in the
treatment of opioid use disorder (OUD).”
Then, Director Volkow testified before the US House of Representatives Appropriations
Committee on May 25, 2022, and stated the following:
“Kratom, most notably mitragynine, has many interesting properties that could
be of value potentially as a medication for pain. Also, interestingly, they could
hold value as a treatment for addiction […] it is important to actually do research
on this substance.”14
Researchers at Johns Hopkins University concluded that 87% of adult consumers using kratom
to treat opioid dependence reported relief from withdrawal symptoms, and 35% replaced the
opioid with kratom within a year. The researchers concluded that serious adverse events are
uncommon even at high consumption rates.15
The NIDA message is that kratom is a harm reduction tool that should be available to
consumers. The science on kratom speaks equally powerfully on its value for consumers, and
the FDA’s own research proves pure and unadulterated kratom is not dangerous to consumers.
CURRENT REGULATORY STATUS OF KRATOM
FDA Commissioner Makary has made it clear during the July 29, 2025 media event on 7-OH that
natural kratom leaf products are not the focus of the FDA, 7-OH product are because the
difference between the products is like “night and day.”
THE DEA’S DESIGNATION AS A DRUG OF CONCERN
14 https://appropriations.house.gov/events/hearings/fy-2022-budget-request-for-the-national-institutes-of-health
15
https://www.dropbox.com/s/bob9xr5jp2bwcg1/Garcia%20Drug%20and%20Alcohol%20Dependence%20kratom%
20study%20Feb%203%202020%20.pdf?dl=0
6
The DEA designated kratom as a drug of concern following the rejection of the
recommendation by the FDA to classify kratom as a Schedule I substance in 2016. That
designation is appropriate for the role the DEA plays in monitoring substances of concern in the
United States. It is important to note the DEA has never designated kratom in any of the
National Drug Threat Assessment (“NDTA”) reports.
The NDTA is a comprehensive strategic assessment of the threat posed to the United States by
domestic and international drug trafficking and the abuse of both licit and illicit drugs. The
report combines federal, state, local, and tribal law enforcement reporting; public health data;
open-source reporting; and intelligence from other government agencies to determine which
substances and criminal organizations represent the greatest threat to the United States.
Kratom does not now, nor has it ever, met the criteria for inclusion in the DEA’s NDTA report.
The Position of the U.S. Congress on Kratom:
First, please consider the views of Representative Jack Bergman (R-MICH.) that he expressed in
an Op-Ed piece in The Hill on July 28, 202316 where he made the following point:
“In their relentless campaign to get kratom reclassified as a dangerous drug, the
FDA has relied on three fallacious and thoroughly debunked objections to its
widespread use: that kratom is unsafe, that it is highly addictive, and that it has
no approved medical use. Even former HHS Assistant Secretary for Health Brett
Giroir felt compelled to call out the FDA for relying on “disappointingly poor
evidence and data and a failure to consider the overall public health” in coming
to such a baseless conclusion. It is rare for a top-ranking HHS official to criticize
the FDA for biased, shoddy work, but in this case the unsupported conclusions
were so egregious that Giroir felt it necessary to publicly criticize them. Likewise,
current HHS Secretary Xavier Becerra acknowledged substantial “knowledge
gaps” regarding kratom and that “kratom-involved overdose deaths have
occurred after use of adulterated kratom products or taking kratom with other
substances.”
Congress itself spoke clearly in the Departments of Labor, Health and Human Services, and
Education, and Related Agencies Appropriations Bill, FY2022, in its Report approved on July 15,
202117 including the following positions on kratom:
PAGE 134:
16 https://thehill.com/opinion/congress-blog/4125241-lets-prevent-the-feds-from-jeopardizing-veteran-addiction-
recovery/
17 https://docs.house.gov/meetings/AP/AP00/20210715/113908/HMKP-117-AP00-20210715-SD003.pdf
7
Kratom. — The Committee recognizes that NIDA-funded research has
contributed to the continued understanding of the health impacts of kratom,
including its constituent compounds, mitragynine and 7-hydroxymitragynine.
The Committee is aware of the potential promising results of kratom for acute
and chronic pain patients who seek safer alternatives to sometimes dangerously
addictive and potentially deadly prescription opioids and of research
investigating the use of kratom’s constituent compounds for opioid use disorder.
The Committee directs NIDA to continue to invest in this important research,
especially considering the increase in overdose deaths during the COVID–19
pandemic.
PAGE 187:
Kratom. — The Committee directs the Secretary to maintain current Agency
policy to not recommend that the substances mitragynine and 7-
hydroxymitragynine, known as kratom, be permanently controlled in Schedule I
of the Controlled Substances Act, either temporarily or permanently, until
scientific research can sufficiently support such an action. The Committee
encourages AHRQ to continue to fund research on natural products that are
used by many to treat pain in place of opioids, including kratom. Given the wide
availability and increased use of these substances, it is imperative to know more
about potential risks or benefits, and whether they can have a role in finding
new and effective non-opioid methods to treat pain. The Committee
recommends an additional $3,000,000 for this research and directs AHRQ to
make center based grants to address research which will lead to clinical trials in
geographic regions which are among the hardest hit by the opioid crisis.
Background on kratom and its safety profile
Publicly available research documents that kratom has a long history of acceptably safe
consumer use, and, when used as an alternative pain management therapy, kratom provides a
far more favorable safety profile for consumers compared to more dangerously addictive and
potentially deadly classical opioid medications. Current scientific research suggests that kratom
provides some pain relief activity on the pain centers in the brain without the dangerous and
potentially deadly respiratory suppression induced by classical opioid medications.
The existing science on kratom does not justify its scheduling under the CSA, nor for kratom to
be added to any local or state Controlled Substances list that would effectively remove it from
consumer access. Here are references to peer-reviewed, published scientific articles addressing
the addiction and safety profile for use of kratom by consumers supporting the position that
scheduling is not appropriate:
8
• Patterns of Kratom use and health impact in the US-Results from an online survey,
Grundmann et al.18
• The abuse potential of kratom according the 8 factors of the controlled substances act:
implications for regulation and research, Henningfield et al.19
• The medicinal chemistry and neuropharmacology of Kratom: A preliminary discussion of
a promising medicinal plant and analysis of its potential for abuse, Grundmann and
Kruegel20
• Kratom use and mental health: A systematic review, Swogger and Walsh21
These studies and other independent peer reviewed evaluations published in scientific and
medical journals provide the profile of a substance that is largely used safely to the benefit of
the estimated 20+ million Americans.
Contact Information:
Mac Haddow
Senior Fellow on Public Policy
American Kratom Association
571-294-5978
mhaddow@americankratom.org
18 https://pubmed.ncbi.nlm.nih.gov/28521200/
19 https://pubmed.ncbi.nlm.nih.gov/29273821/
20 https://pubmed.ncbi.nlm.nih.gov/28830758/
21 https://pubmed.ncbi.nlm.nih.gov/29248691/